Evidence map›Paper›PMID 29335018›Full record

ArticleTrials2018

Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial.

Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Effects of herbal medicine (Integrative medicine research · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Mikyung KimClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Ae-Ran KimClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Hyo-Ju ParkClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Ojin KwonClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Joo-Hee KimClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Eun-Ji ParkDepartment of Obstetrics and Gynecology, College of Korean Medicine, Daejeon University, 62 Daehak-ro, Dong-gu, Daejeon, 300-716, Republic of Korea.
Seon-Eun BaekDepartment of Obstetrics and Gynecology, College of Korean Medicine, Daejeon University, 62 Daehak-ro, Dong-gu, Daejeon, 300-716, Republic of Korea.
Jeong-Eun YooDepartment of Obstetrics and Gynecology, College of Korean Medicine, Daejeon University, 62 Daehak-ro, Dong-gu, Daejeon, 300-716, Republic of Korea.
Jun-Hwan LeeClinical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea. omdjun@kiom.re.kr.ORCID http://orcid.org/0000-0001-5730-6869
Korea Institute of Oriental Medicine · KRDaejeon University · KR

Funding

Korea Institute of Oriental Medicine (KR) K17121
6 · The paper itself

Abstract

backgroundThis study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/

designThis is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure will be the mean change in the Menopause Rating Scale from baseline to week 5. Secondary outcome measures will include the World Health Organization Quality of Life-BREF (WHOQOL-BREF) score, the Blood Deficiency Scoring System score, lean body mass, and blood tests, including serum follicle-stimulating hormone and estradiol concentration. To assess the safety of DJS, a laboratory test will be conducted before and after treatment and the participants will be asked about any occurrence of adverse events every visit. The recruitment rate, completion rate, and medication adherence will also be calculated, to assess feasibility. DISCUSSION: The findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women.

trial registrationClinical Research Information Service (CRIS), Republic of Korea, KCT0002387 . Registered on 25 July 2017.

Indexed as

Double-Blind MethodDrugs, Chinese HerbalFeasibility StudiesFemaleHumansMiddle AgedPerimenopausePilot ProjectsPostmenopauseQuality of LifeRandomized Controlled Trials as TopicRepublic of KoreaSurveys and QuestionnairesSyndromeTime FactorsTreatment OutcomeDrugs, Chinese HerbalClimacteric syndromeDangguishaoyaosanDanggwijagyaksanHerbal medicineMenopausePattern identificationRandomized controlled trialTokishakuyakusanTraditional medicine

Identifiers

PMID29335018
PMCPMC5769552
OpenAlexW2784094359

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.